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Some breast cancers don't respond to taxane therapy, so researchers are now investigating several new treatment options and combinations that may make a difference for some women. Learn about ongoing clinical trials in this interview with Dr. Linda Bosserman of Wilshire Oncology Medical Group, Inc. in Pomona, California.

This program was produced by HealthTalk and supported through an unrestricted educational grant from Bristol-Myers Squibb.

Announcer:

Welcome to this Breast Cancer Education Network program, Clinical Trial Opportunities for Advanced Stage Breast Cancer. Support is provided to HealthTalk through an unrestricted educational grant from Bristol-Myers Squibb. We thank them for their commitment to patient education. Before we begin, we remind you that the opinions expressed on this program are solely the views of our guests. They are not necessarily the views of HealthTalk, our sponsor or any outside organization. And, as always, please consult your own physician for the medical advice most appropriate for you. Now, here's your host, Ross Reynolds.

Ross Reynolds:

If you have advanced breast cancer, you may feel a special urgency to explore new treatment options but also a certain reluctance to participate in clinical trials out of fear of the unknown.

Our guest today, a leading breast cancer researcher and advocate for women's health and community-based medicine, will help dispel some of your fears about clinical trials and discuss some new trials for women with taxane-resistant advanced breast cancer.

Dr. Linda Bosserman is a medical oncologist, president of the Wilshire Oncology Medical Group in the San Gabriel, Pomona and Inland Valley areas of Southern California, and founding partner of the Community/University of California Los Angeles Oncology Network. Welcome to our program, Dr. Bosserman.

Dr. Linda Bosserman:

Thank you for having me.

Ross:

Can you first explain for us what advanced breast cancer is?

Dr Bosserman:

Advanced breast cancer or stage IV breast cancer or metastatic breast cancer all refer to situations where the cancer has spread beyond the breast and lymph nodes. Typically, that means metastases, or spread, into the lungs, the liver, the bones, the skin or the brain.

Ross:

What are the standard treatments currently available for women with advanced breast cancer?

Dr. Bosserman:

There are a range of treatments. Certain women will have their tumor be sensitive to hormone blockade, and there are pills such as tamoxifen [Nolvadex], or the drugs in the aromatase inhibiter class such as Femara [letrozole], Arimidex [anastrozole], or Aromasin [exemestane], or a new Faslodex [fulvestrant] injection that can work by blocking the hormone receptors. Then we go on to use chemotherapy or biologic therapy. There's a range of chemotherapy agents depending on what someone might have had before and what their health situation is. Then there are biologic agents such as Herceptin [trastuzumab], which can work with chemotherapy or alone to specifically inhibit certain types of breast cancer.

Ross:

Before we discuss your clinical trials for women whose breast cancer is taxane-resistant, can you tell us what taxanes are and for which types of patients they are typically prescribed?

Dr. Bosserman:

Taxanes have been a fabulous class of [chemotherapy] drugs that became available over 10 years ago in initial clinical trials [and] that work by specifically stopping cell division. They work on what's called the microtubule, a certain mechanism of how cells divide. Of course, cancer cells divide more often than normal cells, so they are more sensitive. The typical taxanes are Taxol [paclitaxel] and docetaxel [Taxotere], which can be given either weekly or every three weeks. In general, they are very well-tolerated in the sense that they cause almost no nausea whatsoever, but they can have other side effects such as numbness or tingling in the hands or feet or fluid retention or tearing of the eyes or changes in the nails. They can be given for long periods of time. We can have excellent responses even when our previous standard chemotherapies aren't working.

Ross:

Do we know why some breast cancer is taxane-resistant, and can you figure that out before a woman begins treatment?

Dr. Bosserman:

Oh, I wish we could. We know that by the time you have a cancer there are at least 200 genetic mutations in that cell. It's already far outsmarted our immune system, which is why immunotherapy doesn't work for cancer or for advanced metastatic cancer. There are several reasons you could be taxane-resistant. You cannot let the chemotherapy into the cell. You can have what's called multidrug resistance where it gets pumped out rapidly. You could have mutations, so it doesn't bind to the microtubule where it inhibits [cell division]. There are many reasons, but we don't have a good way to know ahead of time who might be resistant.

Now, there's one category of women who may have had taxanes as part of their preventive therapy for early breast cancer. In the unfortunate situation where some of those women have a recurrence within the first six months after finishing, it is very likely that that group was resistant from the beginning.

Ross:

What's available for women when the taxanes just don't work?

Dr. Bosserman:

The drug that's right now FDA-approved for that is an oral pill called Xeloda [capecitabine], which can be very effective. We're looking for numerous other agents, and in fact the FDA has made a very strict ruling that they want to bring new treatments for patients specifically who have taxane-resistant breast cancer and sometimes even capecitabine-resistant breast cancer.

Ross:

You're working on some clinical trials involving newer compounds and combinations for these people with taxane-resistant breast cancer. There are nearly 40 open trials as of right now. Can you tell us about some of them?

Dr. Bosserman:

We have several trials in our group, as do many groups who are heavily involved in clinical trials, in the community or at the academic centers. We have trials for women whose disease might be HER2-positive that might include Herceptin [trastuzumab]. We have some for women who are HER2-negative.

One that we are very excited about is our ixabepilone trial, which is bringing an entire new class of drugs called the epothilones to a Phase II and then Phase III study, trying to see if they are better than the current available medications. Again, this is a trial for women who have had resistance [to taxanes] or previous anthracylines [chemotherapy drugs that are also antibiotics], previous taxanes and previous capecitabine, to find out what the response rates are, hoping they'll be high enough that this might bring this new class of drugs to women.

Ross:

What are some of the potential risks of this new class of drugs?

Dr. Bosserman:

The main risk of this drug seems to be the nerve toxicity - tingling, numbness in the hands and feet. That tends to be a common side effect of the taxanes and some of the new platinum drugs.

Ross:

In addition to the trials that your centers are working on, are there treatment trials underway for taxane-resistant advanced breast cancer at other facilities?

Dr. Bosserman:

There are many different classes of drugs being evaluated now specifically in the category of women who are taxane resistant or taxane- and capecitabine-resistant and have had previous anthracylines. Across the country, this is our greatest hope to find new classes of drugs, which alone or with subsequent combinations, will give us better long-term survival rates.

Ross:

Now, you can't do a trial without someone signing up for it, Dr. Bosserman, and I understand enrollment numbers for many clinical trials are relatively low. Why do you think this is true?

Dr. Bosserman:

The overall number of adults in America with cancer who enter a clinical trial is low. Actually, we've been tracking this in our group and for women who are eligible, at least 90 percent will go on a trial when it's available and the time is taken to explain it to them.

Everyone knows in metastatic breast cancer in 2004 and 2005, we don't have a cure. The average survival for women with metastatic breast cancer is still about two years, meaning half will die before two years, and half will live longer. With some of these new drugs, I have people living five and 10 years when we're lucky, but it doesn't work for everybody. So women realize being in a clinical trial will give them the opportunity to get a new drug. If it works, great. If it doesn't they can move on to any of the standard agents, but if it does work for them they have the opportunity to get something that may be five or 10 years away from being standard and available.

Ross:

Why should women living with advanced breast cancer be enrolling in clinical trials?

Dr. Bosserman:

Well, first of all, to help themselves find new, potentially effective drugs. Most of the trials are either randomized against whatever the standard would be, so you're not getting any less than the best available care, and you're helping move the field forward. A good example will be women who entered the Herceptin [trastuzumab] trial, the antibody that tripled the one-year survival [rate] for women with metastatic breast cancer. The women who entered that trail were given that drug about four to five years ahead of it becoming available and have had marked improvement in their survival. Getting on a trial offers you, potentially, some of the best new drugs being developed across the country.

Ross:

What should women know about the downside of enrolling in clinical trials?

Dr. Bosserman:

[Women should know about] he paperwork and the time and the fact that we have a very strict adherence to informed consent and the investigator review oversight process. Everything is looked at. Every medication you take, whether you get an antibiotic for a cold in the middle of the treatment, they want to know what day you started it and what day you stopped it. We're going to collect data: Is what the doctor says accurate? What were the patient's side effects? - so that we know when we bring a drug to market as much as possible about it.

Before you go on a trial, you are often handed a 16- to 25-page consent form, which is written as much by the lawyers as by the doctors, and patient advocates tell you a lot more than you may want to know about your treatment. I tell patients, if you had to write the same thing about aspirin, you might never take an aspirin. But we do try to fully inform patients about everything we know about the drug - any possible side effects, what to watch for, what we think the pros and cons and the benefits will be - so they can make an informed independent decision to participate or not.

Ross:

We're coming to the end of our program, Dr. Bosserman. Could you give our listeners some practical tips on how to find clinical trials that may be right for them, and also how to stay informed on the latest research developments?

Dr. Bosserman:

The Web has been really revolutionary there, and the National Cancer Institute has taken a very serious stand in trying to encourage everyone involved in clinical research to put their clinical trials on the Web. So the National Cancer Institute Web site, www.cancer.gov, is a way to get to that, [or] www.clinicaltrials.gov. Talk to your oncologist. Our oncology group has its own Web site, at Wilshire Oncology. UCLA has a Web site www.cancer.mednet.ucla.edu/patientinfo/index.html. So, you can begin searching for the various trials that might meet your needs and then investigate further by calling the investigators or a local group that's participating.

Ross:

We really appreciate your taking the time to talk with us about your research, Dr. Bosserman.

We've been discussing clinical trials for taxane-resistant advanced breast cancer with Dr. Linda Bosserman, medical oncologist and President of the Wilshire Oncology Medical Group, in the San Gabriel, Pomona and Inland Valley areas of Southern California. To learn more about some of the trials discussed in this program, you can call 1-877-526-7323. From all of us at HealthTalk's Breast Cancer Education Network, I'm Ross Reynolds. We wish you and your families the best of health.

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